A Phase III Study of Cabozantinib versus Placebo in Patients with Liver Cancer Who Received Previous Therapy with Sorafenib

Protocol

13-151

Full Title

A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs Placebo in Subjects with Hepatocellular Carcinoma Who Have Received Prior Sorafenib

Phase

III

Purpose

Cabozantinib (XL184) is a drug that blocks several proteins (called MET, RET, and vascular endothelial growth factor receptor 2) that help keep cancer cells alive. It is approved for treating thyroid cancer, and has shown promise against liver cancer in prior clinical trials.

In this study, researchers are comparing the effectiveness of cabozantinib versus a placebo (inactive pill) in patients with advanced hepatocellular carcinoma (liver cancer) whose disease persists despite prior treatment with the drug sorafenib. Patients will be randomly assigned to receive cabozantinib or a placebo in a 2:1 ratio. This means that two-thirds of the patients will receive cabozantinib, and one-third will receive a placebo.

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

Patients must have metastatic liver cancer that is not responding to at least one regimen of standard systemic treatment which included sorafenib.

At least 2 weeks must have passed since completion of prior chemotherapy, 4 weeks since radiation therapy, and 6 weeks since any radionuclide treatment and entry into the study.

Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.

This study is open to patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Ghassan Abou-Alfa at 646-888-4184.

Clinical Trials

Clinical trials can offer you access to a new, experimental treatment before it is available to most patients. Joining a clinical trial is also a way to make a valuable contribution toward the fight against cancer.